NCT06972511

Maximal Tumor Eradication for Oligometastatic Prostate Cancer

Recruiting now Phase 2, PHASE3 Last updated 15 May 2025

What this trial tests

Phase 2, PHASE3 trial testing neoadjuvant apatamide plus ADT + radical resection of prostate cancer + extended lymph node dissection + radiotherapy of metastases in Oligometastatic Prostate Cancer in 120 participants. Currently enrolling.

Timeline

20 August 2023

Primary endpoint
30 December 2025

30 December 2027

Quick facts

Lead sponsor	RenJi Hospital
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	20 August 2023
Primary completion	30 December 2025
Estimated completion	30 December 2027
Sites	1 location across China

Drugs / interventions tested

• neoadjuvant apatamide plus ADT + radical resection of prostate cancer + extended lymph node dissection + radiotherapy of metastases
• Standard ADT treatment — full drug profile →

Conditions studied

• Oligometastatic Prostate Cancer — all drugs for Oligometastatic Prostate Cancer →

Sponsor

RenJi Hospital

Who can join

Adults 18 to 75, male only, with Oligometastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In China, the incidence of prostate cancer is increasing in recent years, and it has ranked 5th among common male tumors and 1st in urinary tumors. Unlike developed countries in Europe and the United States, in China, because prostate-specific antigen (PSA) screening has not been widely popularized, and early prostate cancer is mostly asymptomatic, about 13%-26% of prostate cancer patients have progressed to metastatic hormone-sensitive prostate cancer (mHSPC) at the time of initial diagnosis. Compared with localized prostate cancer, the 5-year survival rate of mHSPC is only 29.3%, which is prone to symptoms such as bone pain, pathological fracture, hematuria, and dysuria and seriously decrease the survival and quality of life. As a result, it is of great significance to carry out more refined management of mHSPC, explore more scientific treatment options, and delay the time to CRPC, which is of great significance for improving the prognosis and quality of life of patients and reducing medical burden. However, there is still no standard treatment strategy for OMPC patients which need more clinical exploration.

Treatment of prostate primary in oligometastatic prostate cancer (OMPC) may improve survival and do not significantly increase complications. Radiotherapy showed excellent therapeutic effects on metastatic lesions, prolonged survival and without increasing significant adverse effects. In 2019, The New England Journal of Medicine reported a TITAN study that combining apatamide with ADT for metastatic hormone-sensitive prostate cancer, which significantly reduced the risk of death (82.4% VS 72.5%, P=0.005), and improved progression-free survival (68.2% VS 47.5, P \<0.001) without increasing adverse effects of treatment. In 2020, Johns Hopkins University published a phase I clinical study of radical treatment of 12 cases of OMPC. Patients were treated with neoadjuvant docetaxel chemotherapy or abiraterone, combined with radical prostatectomy for primary lesions, and stereotactic radiation for bone metastases to achieve the purpose of complete tumor eradication. Preliminary results showed that no additional complications were found except neutropenic fever in two cases. At the same time, the proportion of PSA maintained undetectable in 1,2,3 years was 12 / 12 (100%), 10 / 12 (83%) and 8 / 12 (67%), respectively, showing good treatment results.

Since 2014, the applicant has rich research experience in the treatment of oligometastatic prostate cancer and our results showed that systemic therapy combined with local tumor reduction therapy can confer a survival benefit for OMPC patients without a significant increase in complications. This clinical trial aimed to analyze the clinical efficacy and safety of maximal tumor eradication strategy for oligometastatic prostate cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.